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FDA Warning Letters and Form 483 Inspectional Observations, while not final determinations, are extremely important for companies to fully evaluate and resolve. What may seem like simple deficiencies in your quality system can be just the tip of a huge compliance iceberg floating just beneath the surface.

All too often these issues become low priorities for those responsible for quality assurance and regulatory compliance, opening the door to costly enforcement actions down the road when seemingly small issues develop into much more serious problems.

FDA Warning Letters are official notices informing manufacturers and other companies they are in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act while providing them with an opportunity to voluntarily correct violations before initiating enforcement action. In the words of the FDA, a Warning Letter:

“...notifies a company that the FDA considers one or more products, processes, practices or other activities to be in violation of theFederal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes.”

Following an FDA inspection, you may be issued an FDA Form 483––a form listing Inspectional Observations of current issues and/or potentially problematic conditions.

First and foremost, it’s important to take these observationsseriously. Although it does not represent the FDA’s final determination on compliance, deciding not to respond to FDA 483 observations within the 15-business day window will almost certainly result in a Warning Letter or further enforcement action.

Earlier this May, the Worcester Telegram & Gazette sat down with The FDA Group's President and CEO, Nick Capman, to discuss the the company's history and role in helping pharmaceutical, medical device and biotechnology companies with a variety of GxP auditing, remediation and regulatory requirements.

The discussion also explored how The FDA Group seeks to stand out from the competion as well as the challenges and rewards that come with business ownership.

Read a snippet of the conversation below, or click here to read the full CEO One on One interview on telegram.com.

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